After a brisk, 30-minute hearing, a U.S. House panel cleared a bill re-authorizing the user fees medical device and pharmaceutical companies pay the FDA to have their products reviewed.
The House Energy & Commerce Committee’s health subcommittee cleared the measure on a voice vote at about 10:30 this morning, after adding an amendment from chairman Rep. Joe Pitts (R-Penn.) to address "technical changes to the committee draft recommended by the FDA and stakeholders," Pitts said during the hearing.
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A companion bill fairly flew through the Senate’s Health, Education, Labor & Pensions Committee in April. The House version must still be passed by the full Energy & Commerce panel before heading to the chamber’s floor. Democrats managed to deflect a Republican attempt to alter the watchdog agency’s mission statement to include promoting job growth, competition and economic growth were left by the wayside.
The Senate HELP Committee forwarded the bill with near unanimous support, adding some language to beef up the FDA’s safety regulations and allow the federal watchdog agency to conduct safety studies of devices after they’ve been approved and to grant conditional approvals contingent on further trials.
Several other bills were withdrawn ahead of the panel vote, including Sen. Jeff Merkley’s (D-Ore.) amendment to give the FDA "predicate nullification" authority – the ability to reject 510(k) applications based on recalled devices.
Lawmakers are further motivated to maintain bipartisan momentum on the bill before political grandstanding threatens to take over the conversation when the Supreme Court issues its ruling on President Barack Obama’s landmark health care reform law next month.
AdvaMed issued a statement late in April commending legislative efforts toward approval of the user fee acts, which have thus far avoided much of the bipartisan squabbling that often accompanies such items.
"Mark up is an important milestone in the reauthorization process, and we are encouraged by the bipartisan support this legislation has received," AdvaMed chairman & CEO Stephen Ubl said in a prepared statement. "We are hopeful it will remain on track to pass in a timely fashion."
The device advocate was an instrumental player in drafting the new user fee deal, and new AdvaMed chairman and Zimmer (NYSE:ZMH) president & CEO David Dvorak named passage of the latest user fee agreement as 1 of the top priorities of his 2-year term.
"There are very powerful and very well-financed interests here that would be extremely upset if this were to get bogged down," National Coalition on Healthcare president John Rother told Politico. "I think that the combined power of the industries regulated by the FDA would not be something anybody would want to tangle with when it comes to getting this legislation done. I just don’t see it happening."
The White House Office of Management & Budget in March month signed off on the Medical Device User Fee & Modernization Act, which doubles the user fees med-tech makers pay for agency reviews, from $295 million over 5 years to $595 million. In return, the FDA committed to meeting a series of performance goals.
The bill will head to the House Energy & Commerce Subcommittee tomorrow for an open markup session.
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